Communication from the Commission to the Council and the European Parliament on the control of new synthetic drugs (designer drugs)
Date: 1997-05-23
Institutions: European Commission
Subjects: administrative cooperation, chemical product, customs inspection, marketing, narcotic

COMMISSION  OF THE  EUROPEAN  COMMUNITIES 

Brussels,  23.05.1997 
COM(97) 249  final 

COMMUNICATION  FROM THE COMMISSION  TO THE COUNCIL AND THE 
EUROPEAN  PARLIAMENT ON THE CONTROL  OF NEW SYNTHETIC  DRUGS 
(DESIGNER  DRUGS) 

COMMUNICATION FROM THE COMMISSION  TO THE COUNCIL AND THE 
EUROPEAN  PARLIAMENT ON THE CONTROL OF NEW SYNTHETIC  DRUGS 
(DESIGNER  DRUGS) 

I. 

INTRODUCTION 

Every year,  large amounts of new synthetic drugs  are produced  in Member  States  of 
the  European  Union.  The  consumption  of  these  drugs  is  on  the  rise,  particularly 
among  very  young  people.  This  development  poses  a  serious  threat  to  their  health 
and lives and it is a source of great  distress to our citizens. They expect urgent  action 
at all levels to reverse this trend. 

Firm  action  in  this  area  is  also  needed  to  maintaining  the  credibility  of  the 
considerable efforts  the European  Union  is undertaking  in combatting the  cultivation 
and production of narcotic drugs throughout the world. 

The  sharp  increase  of  illicit  production,  trafficking  and  use  of  these  new  synthetic 
drugs in Europe can be attributed  to  several  factors  which  make them  different  from 
more traditional plant-based drugs. These include: 

• 

• 

• 

• 

• 

the ingredients needed for their production are all available within the EU, meaning that 
they can be produced locally, close to the areas of consumption. 

they  are relatively  easy  to  prepare,  with  precursors freely available in the  market  and 
requiring only a rather unsophisticated infrastructure  such as abandoned warehouses or 
even mobile homes; 

they are cheaper than cocaine or other plant based drugs which are the other "more 
traditional" main stimulants in illicit markets and have a longer-lasting  effect; 

they are seen as fashionable  and part  of youth  culture in some countries.  There is no 
strong link with theft or violent crime; 

the public health risk is frequently underestimated in public perception.  It is not always 
easy  to  recognize  the  difference  with  similar,  licit  products  which  are  often  used 
functionnally,  e.g. in certains professions to increase endurance. 

They  do,  however,  also  have  features  in  common  with  plant-based  drugs,  notably  the 
analogous threat they can pose to human health and the danger they represent, particularly 
to young people. 

The  Community  action  programme  on  the  prevention  of  drug  dependence  already 
contributes  to  improving  public  awareness  and  developing  appropriate  health  and  social 
responses  to  this  threat.  In  particular,  this  programme  currently  gives  support  to 
transnational  pilot  projects  aiming  to  build  up  a  system  to  recognise  trends  in  drugs 
consumption among the young, to assess prevalence of drug use in particular settings such 
as Techno-scenes and to develop transnational exchange of data. 

The  European  Commission,  acting  together  with  the  Presidency  of  the  Council  of 
Ministers and the European Parliament,  has on several occasions highlited this problem 
and  called  for  priority  action  at  the  level  of  the  European  Union.  The  fight  against 
drugs  became  a  central  theme  during  the  Irish  Presidency  and  the  Dublin  European 
Council clearly pointed  out the need to  supress domestic production  and trafficking  of 
synthetic drugs within our Member States. 

This  Communication  represents  the  Commission's  contribution  to  following  up  that 
instruction. 

IL 

NATURE OF THE PROBLEM 

The world-wide nature of the problem is reflected  in the increasing attention directed to it 
in the relevant international organisations within the United Nations family  : World Health 
Organisation, International Narcotics Control Board, Commission on Narcotic Drugs. 

There exists a major international legal instrument for tackling the problem at world level, 
in the shape of the 1971 United Nations Convention on Psychotropic Substances. 

Ratified  and  implemented  by  146  nations,  and  subsequently  enhanced  by  the  relevant 
provisions of the  1988 United Nations Convention against Illicit Traffic  in Narcotic Drugs 
and  Psychotropic  Substances,  the  1971  Convention  offers  the  essential  international 
framework  for the scheduling and interdiction of the main synthetic drugs identified  at that 
It  contains  an  updating  mechanism,  but  recent 
time  as  posing  a  danger  to  health. 
experience has shown that this mechanism, requiring a world-wide international consensus, 
is  slow  to  mobilise  -  and  certainly  not  flexible  or  rapid  enough  to  keep  pace  with  the 
appearance on the market of new synthetic drugs often  deliberately designed to circumvent 
the Convention's provisions. 

The European Union  and  its Member  States are, however,  equipped  -especially since the 
entry into force of the TEU - with a range of instruments and possibilities to react quickly 
and  effectively  among  themselves  to  address  the  moving  target  represented  by  new 
synthetic drugs. 

Synthetic drugs, like plant-based drugs, are dependent upon certain precursor chemicals. Of 
the 22 substances controlled through EC legislation in implementation  of the  1988 United 
Nations  Convention,  8  are  directly  relevant  to  synthetic  drugs  l  and  others  need  to  be 
added. 

Furthermore, with regard to end products (i.e. the synthetic drugs themselves, as opposed 
to their precursor chemicals) all EU Member States have introduced in their legislation the 
control  of the psychotropic  substances placed under  control by the  1971 UN  Convention 
(see ANNEX I). This Convention  provides for  the control  of classified  substances  on the 
basis of their strict chemical definition. 

Since,  however,  the  amphetamine-type  stimulants  are very  similar  in  chemical  structure, 
they  lend  themselves  easily  to  minor  structural  modifications  to  lead  to  a  different  end-
product.  These modifications can be motivated by various factors : 

the deliberate effort  to circumvent legislation on precursors or, 

(i) 
(ii)  the possible use and availability of non-listed precursors; 
(iii)  the deliberate manufacturing of amphetamine-type stimulants not covered by 

national law or international convention, and sometimes referred to as "designer 
drugs". 

It is chemically possible to obtain a large number of structures altered in this way, in which 
however  the  basic  composition  of  the  amphetamine  remains  unchanged.  Some  such 
derivatives  currently  popular  in  Europe  thus  fall  outside  the  scope  of  the  1971  UN 
Convention on Psychotropic Substances.  Although in theory this problem could be tackled 
though regular modification  of any of the lists of the  1971 UN Convention, such a process 
can be expected to take 2-3 years. Thus an important lacuna can exist between the moment 
when new synthetic drugs are introduced  in the illicit market  and  when they are added  to 
one  of the  lists of the  UN  Convention.  During this  intervening  period,  and  unless  other 
defences are mounted, there is a risk that the new synthetic drugs can circulate freely since 
the criminal law of several Member States does not allow  control to be legally excercised 
on substances which are not (yet) put under a list of controlled substances. 

HI. 

SOME RESPONSES AT NATIONAL LEVEL 

In  countries  affected  by  the  problem  of  synthetic  drugs,  three  different  categories  of 
response appear to have been adopted, in addition to the control system based on the strict 
chemical  definition  of the  substances  (the  control  "by  name"  of  the  substance)  which  is 
foreseen in the 1971 UN Convention on Psychotropic Substances : 

1  phenyl-2-propanone  (P2P),  ephedrine,  pseudoephedrine,  safrole,  isosafrole,  piperonal, 
3,4 methylenedioxy-P2P and phenylacetic acid. 

(i) 

the "generic appoach" : 

some Member  States  (United* Kingdom,  Ireland)  have  introduced  in their  misuse  of 
drugs  legislation  the use  of generic  definitions  for  various  families  of drugs  to  catch 
those  new  synthetic  drugs  which  do  not  appear  on  the  Schedules  of  the  UN 
Conventions.  In Germany,  a new bill which would  introduce the generic  approach  is 
being discussed at the mterministerial level and with the Lander before being presented 
at Parliament. 

The use of generic definitions has the advantage of criminalising by anticipation a great 
number  of  groups  of  synthetic  drugs  that  could  eventually  appear  on  the  market. 
Although  it  can  not  cover  aJl the  potential  drugs  of  abuse  which  may  eventually  be 
produced  on  the basis  of  a  single  molecular  structure,  it  makes  it  more  difficult  for 
clandestine laboratories to produce  synthetic drugs which remain outside of the scope 
of criminal law; 

(ii)  the "emergency list" approach 

other  Member  States  (Germany,  The  Netherlands)  have  introduced  into  their 
legislation  an  urgency  procedure  to  control  legally,  on  a  provisional  basis,  new 
substances which appear on the market before the full  introduction of these new drugs 
into the relevant schedule.  This system allows for a quick reaction to the abuse of and 
trafficking in "new" synthetic drugs and can give rise to the use of criminal sanctions; 

(iii)  the "analogue" approach : 

this is the system preferred by the US Drugs Enforcement  Agency and is set out in the 
1986  amendment  to  the  Controlled  Substances  Act  (CSA)  in  the  form  of  the 
Controlled Substance Analogue Enforcement Act. 

This Act  provides that  criminal  sanctions  apply to  the  activity  of  manufacturing  and 
distributing "controlled  substance analogues" intended for human consumption.  These 
substances  are  considered  "analogues"  if  they  produce  substantially  the  same 
psychoactive effect  as controlled substances and have chemical structures substantially 
similar  to  those  of  controlled  substances.  These  substances  are  therefore  prohibited 
unless  it  is concluded  in  a  court  of  law  that  the  assumptions  were  unfounded.  It  is 
important  to  note  that  there  is no  list  of  controlled  substance  analogues.  Since  the 
introduction  of  the  1986  amendment,  the  DEA  have  observed  a  decrease  in  the 
production  and  distribution  of  analogues  and  attribute  this,  in  particular,  to  the 
analogue  statute which has had  the effect  of  making  the trafficking  of new  synthetic 
drugs too risky and uncertain to be worth the effort  for the profit involved. 

IV.  ELEMENTS FOR A RESPONSE AT THE LEVEL OF THE EUROPEAN UNION 

THE DUBLIN EUROPEAN COUNCIL 

Heads of State and Government, meeting in Dublin in December  1996, identified  the issue 
of  synthetic  drugs  as  needing  priority  attention  both  within  the  European  Union  and 
between  the  Union  and  third  countries,  particularly  the  Central  and  Eastern  European 
countries.  In doing  so, they  specifically  endorsed  the  report  on  drugs  they  had  received 
from  the Council, and the Joint Action of 17 December  1996 concerning the approximation 
of the laws and practices of the Member States in the field of drugs. 

The report in question stated clearly that synthetic drugs was an area "where  insufficiencies 
exist"  and  "needed  to  be tackled  at  three  levels:  (a)  legislation;  (b)  practical  cooperation 
against  production  and  trafficking,  including  improved  cooperation  between  national 
authorities and the chemical industry; and (c) international cooperation". 

As for the Joint Action, it states in its Article 5 that there is a need for more convergence in 
Member  States  legislation  in  the  area  of  synthetic  drugs  and  provides  that  the  Member 
States "shall endeavour to draft convergent legislation to the extent necessary to make up 
legal ground  or fill  legal  vacuums as  regards synthetic drugs. In particular  they shall 
promote  the  establishment of  a  rapid  information system  to  enable  such  drugs  to  be 
identified as substances liable to  be prohibited  as  soon  as  they appear anywhere in  a 
Member State". 

Thus the European Council has given clear guidance on how it wishes to  see the problem 
addressed. The Commission considers that this invitation to ensure an appropriate and swift 
control  on  new  synthetic  drugs  and  their  chemical  precursors  should  be  followed  up  by 
means of a number of initiatives, which could be taken on a step by step basis. 

As a first and early step, the Commission favours action on three  fronts: 

-  chemical  precursors  (starting  material):  Proposals  for  amending  the  existing 
Directive and Regulation will be presented by the Commission by October 1997. 

-  new synthetic drugs (end-products): the creation  of an early warning system  for 
synthetic drugs, including a mechanism for risk assessment. 

- a commitment by Member States to criminalise production  and trafficking  of new 
synthetic drugs declared dangerous. 

There is also a case for  an examination  at EU  level  of whether  at  a later  stage additional 
instruments might enhance the effectiveness  of the fight against the illicit trafficking  in and 
use  of  synthetic  drugs,  based  perhaps  on  a  discussion  of  the  relative  merits  of  the 
"emergency list" approach,  the "generic approach" or the " analogue approach" mentioned 
under chapter III above. 

ACTION FORESEEN ON PRECURSOR OF NEW SYNTHETIC DRUGS 

An  effective  way  of  approaching  the  problem  of  new  synthetic  drugs  consists  in 
ensuring a better monitoring of the trade in the chemical substances which are the basic 
ingredients used in manufacturing new synthetic drugs. 

It is not  possible to monitor this trade under the classical  methods  of  control  such as 
those provided for under the present  Community legislation on precursors. The nature 
of  the  chemicals  involved  and  the  particular  conditions  under  which  new  synthetic 
drugs can be manufactured impede the use of these strict control mechanisms. 

This is the reason why  a broad  consensus  exists  at the  international  level  to  look  for 
other monitoring mechanisms such as a "special  surveillance list", that would be more 
flexible  for both trade and public authorities  and thus would  be  really  efficient,  given 
this  specific  context.  This  is  in  particular  the  approach  the  US. DE A  follows,  more 
stringent mechanisms being unrealistic in this case. 

Technical  work  is currently  in progress  in the  competent  Community  fora.  They  will 
result  in  formal  proposals  by  the  Commission,  to  be  presented  to  the  Council  next 
October,  after  further  discussions  with the Member  states  and the  relevant  trade and 
chemical industries organisations. 

These proposals will address the following aspects: 

- list of new products to be monitored, 
- new methods for the monitoring of the products concerned, 
- ways and means of adapting rapidly in the future the list of these products. 

They  will  concern  amendment  of  the  existing  directive  concerning  manufacture  and 
placing  on  the  market  of  the  chemical  substances  concerned  within  the  EU  and 
amendment of the regulation concerning the international trade. 

Moreover,  when  a  common  position  has  been  adopted  within  the  Council  on  this 
question,  the  Commission  intends  to  ask  for  a  negotiation  mandate  vis-à-vis  the 
Central and Eastern European Countries on the territory of which new synthetic drugs 
are produced.  In parallel,  the Phare programme  resources will be used to  continue  to 
help  these  countries  to  prepare  and  to  adapt  their  own  legislation  on  precursors, 
namely in view of their accession to the EU. 

Finally,  some efforts  will  have to be made in short term,  in order to  allow  the  EU  to 
speak with one voice within the international meetings that should take place from next 
July,  in  view  of  the  preparation  of  the  1998  UN  General  Assembly  Special  Session 
which wili be devoted to drugs and in which precursors will occupy a large place. 

The  Commission  will  do  the  necessary  work  in  order  to  ensure  that  the  necessary 
coordination  is  done  within  the  Council  and  that  it  results  in  a  concrete  Community 
position on this topic, thus allowing the EU to maintain a leading and  constructive  role 
in these international  fora. 

Details of this action are described  in Annex II. The input  of Member  States experts in 
this process will be very important  for  achieving the objectives  for  action  described  in 
this Annex. 

CREATION OF  AN EARLY WARNING SYSTEM 

An effective  early warning system for new synthetic drugs appearing in the Member  States 
should build on existing information  gathering bodies and avoid duplication.  In addition to 
national sources, the two most appropriate such bodies at EU level are the Europol Drugs 
unit (EDU) for information  coming from the law enforcement  agencies, and the European 
Monitoring  Centre for Drugs  and Drug Addiction  (EMCDDA), by means of the national 
focal points of REITOX, for information coming from the health and social services. 

To  this  can  be  added  data  concerning  chemical  precursors  diverted  into  the  illicit 
manufacture of synthetic drugs which will continue to be examined by the Drugs Precursors 
Committee  set  up  under  Regulation  3677/90  and  Directive  92/109  to  which  the  early 
warning system will provide an added value. 

All this relevant  information  will  need  to  be  assessed  by experts  in order  to  evaluate  the 
risks  posed by these new substances. 

The Commission believes that this assessment would best be carried out in the  framework 
of a Technical Committee to be set up, which would involve representatives from not only 
Member States but also from the existing relevant agencies (EMCDDA; the Agency for the 
Evaluation of Medicinal Products; and the Europol  Drugs Unit)  . The Commission would 
seem  to  be the right institution  to  chair  such  a  committee,  as  well  as  contributing  to  its 
work on the basis of information  on synthetic drugs coming from the existing Community 
instruments  related  to  (i)  the  international  control  and  intra-Community  surveillance  of 
chemical  precursors,  (ii)  the  Community  action  programme  on  the  prevention  of  drug 
dependence, (iii) the Community framework research and development programme. 

The Committee, having conducted its risk assessment  on the basis of the information from 
different  sources  (law  enforcement,  health  and  social  services)  should  make  its 
recommendation  for  action  at  the  level  of  the  Council,  including,  where  appropriate  and 
agreed,  action  to  ban  and  criminalise  the  production  and  trafficking  of  the  dangerous 
substances identified. 

CO-OPERATION WITH CENTRAL AND EASTERN EUROPEAN COUNTRIES 

Co-operation between EU Member States and the Central and Eastern European countries 
in fighting against  illicit  drugs  trafficking,  in  particular  synthetic  drugs,  received  special 
attention at the seminar and meeting of the Council's Drugs and Organised Crime Working 
Group with  the countries of Central and Eastern Europe and the Baltic States which took 
place  on  23-24  October,  1996.  This  gave  rise  to  a  number  of  useful  recommendations 
which should be followed up: 

Development  of a network  of law enforcement  focal  points  for  synthetic  drugs  and  drug 
precursors  between  Member  States  of th  European  Union,  the  countries  of  Central  and 
Eastern  Europe  and  the  Baltic  States,  making  use  of  the  existing  list  of  contact  points 
maintained  in  connection  with  the  European  Community  legislation  on  the  control  of 
precursors; 

Combatting misuse of synthetic drugs and precursors by: 

the  building  of  a  network  of  expertise  from  the  European  Union  and  associated 
countries  to  facilitate  the  enhancement  of the  knowledge  necessary  to  tackle  the 
problem,  as  well  as  the  rapid  exchange  of  information  (profiling,  production 
methods, etc.) and the adoption of the necessary legal provisions; 

the  surveillance  of  non-listed  precursors  used  in  illicit  production,  involving  co 
operation by law enforcement  and other appropriate authorities. To this extent the 
importance of voluntary  agreement  and  concluding Memoranda  of Understanding 
with the trade were underlined. 

In the field of precursors, adaptation of the relevant PHARE project to ensure that the pre-
accession  procedures  presently  underway  (adaptation  of  legislation  to  EU  standards,  ie 
Regulation  3677/90  and  Directive  92/109)  reflect  any  possible  amendment  of  the  EU 
legislation to cover chemicals diverted for the illicit manufacture of new synthetic drugs. 

CO-OPERATION WITH OTHER KEY EU PARTNERS 

Given the global  and  growing  nature  of this  synthetic  drugs  problem,  as  reflected  in the 
Resolution  adopted  at  the  1995  UN  Commission  on  Narcotic  Drugs  (CND)  and  in  a 
number  of  expert  meetings  which  have  taken  place  within  the  UN  bodies  concerned, 
particularly  UNDCP  and  WHO,  it would  be  appropriate  also to  share the  EU's thinking 
with its main partners, notably the USA, Canada and Japan. 

This  could  in  turn  lead  to  possible joint  initiatives  with  them  in  international  fora,  for 
example at  the UN Commission on Narcotic Drugs (CND) in view of the forthcoming UN 
General Assembly (UNGA) special session on drugs (1998). 

Tnhlc  l b:  Scheduling  of  individual  substances  under  Ihe  1971  Convention  on  Psychotropic  Substances 
(Nole: Only llic year  ofllic  lli-l  inclusion of a substance  into  any of the Schedule"; ofllic  1'sycliotmpic Convention  has hern  considered) 

J 28 7 

vm 

1252 

Sdi. 

I 

1221 
i 
w:\ 
)MIIP 
)Mr 

2?<J 

_2ftl 

&M 

rticycliilinc 

olicyclidinc 

tcnocyclidine 

ANNEX  f 

1221 

1221 

etryptamine 

nellicntrimone 

122<J 

Ml)!;  -

N-OII-MDA 

•1-mcthyl-
aminorex 

. 

...... 

1 

_ 

mclnnifclaml 
nc racenialc 

dronabinol 

zipeprol 

vm. 
\K)l\ 

1X86 

('athinonc 

MIM 

DMA 

DOJVI 

MDMA 

MMIM 

I'MA 

1 MA 

• 

fcnclylline 

fc^anifclamlnc 

Icvomctha/n-
phclnminc 

i.sn 

incscntinc 

pHrnliexyl 

psilocinc 

psilocybiuc 

SIP/DOM 

Ictrnhydrocanna-
biiioles' 

RinfctBininc 

medoqunlone  i 

-Û 

1 
In 

dexmnfclftmiric 

1 mctainfctnminc 

melliylphenlilnte 

pltettcyclidinc 

phctmielrfulnc 

lit 

oinobnrbitnl 

cyclobnrbitnl 

peitdtfocinc 

cnlliinc 

butnlbital 

biiprciiorpliinc 

1 

-

I 

. 

I 

1 
I 

dronabinol  (ilel(a-9-lctrahydrocaiinabino!) wa.s trans lei red  from  Schedule  I to Schedule  II in  1991. 

T a b ic  l b: Scheduling  of individual  substances  under  tlie  1971  Convention  on Psycliotropic  Substances 
(Note:  Only  the  year  of the  first  inclusion  of a substance  into  nny of the  Schedules  ofllic  Psychotropic,  Convention  has been  considered) 

1 

SfilL 

1211 

J080 

12K.L 

12M 

l')K5  VM 

1257 

10KR 

iyx'2 

MJ'JO 

1921 

JOOS 

1 

*

*

-• 

auiinorcx 

broti/olam 

mesoeaib 

glutcthimide 

III 

pentobarbital 

secobarbital' 

IV 

amfcpramone 

benzfetaminc 

alprazolam 

clihimfctmninc 

allobaibital 

pemoline 

inida/nlam 

barbital 

ettichlorvynnl 

ethinamnte 

Icfclamine 

meprohamale 

metliaqualone' 

mclhylpheno-
barbital 

melhyprylon 

phénobarbital 

piprndrol 

ina/indol 

brotnazepam 

fcncainfnmin 

butobarl)ital 

phem!imelra?.inc 

camazepam 

fenproporcx 

sccbutabarbital 

phenlenninc 

chlnrdiazcpoxi 
dc 

inefcnorcx 

vinylbital 

cloba/am 

propylhexedrine4 

clonazepam 

pyrovalcronc 

clorazcpafc 

clonazepam 

clnxa/nlant 

dclora/c[)ani 

diazepam 

eslaznlam 

ethyl 
lollii/cpalt: 

3Sccobarbital  wa.s transferred  from  Schedule  III lo Schedule  II in I9XX. 

^Propylhexedrine was deleted  from  Sch. IV in 1991. 

'Methaqualonc  wa.s transferred  from  Schedule  IV lo Schedule II in  1978. 

Table  lb:  Scheduling  of individual  substances  under  the  1971 Convention  on  Psychotropic  Substances 
(Note: Only the year  of the first  inclusion  of a substance  into any  of the Schedules of the I'sychotropic Convention has been  cnnsidercil) 

1 

I'M 5 

1256 

12» 2 

l ^ RR 

1W) 

J22i> 

1221 

ITJ1 

Sçlh 

1211 

12KQ 

12M 

IV 

12M 
(ludia/cpain 

lluuilra/epam* 

nitrazepam 

hala/epam 

lialoxazotaiu 

kcta7olam 

loprazolam 

lorazepani 

lormetazepam 

medazepam 

nimetazepam 

nitrazepam 

nordazepam 

oxazepam 

oxazolam 

pina/cpam 

pra/epatn 

lemii/epam 

lelra/cpam 

triazolam 

sFlunilrazcpam  wa.s transferred  from  Schedule  IV to Schedule  III  in  1995. 

ANNEX II 

ACTION AGAINST PRECURSORS OF NEW SYNTHETIC DRUGS -

1.  The issue 

Compared  with  other  types  of  drugs  and  psychotropic  substances,  the  emergence  and 
development  of  new  synthetic  drugs  (NSDs)  poses  a  special  problem  because  their 
chemical  structure changes frequently  and because many types of precursors  (themselves 
very variable) can be used for making them. 

Since almost all of these chemical  substances are used for legal purposes, action is needed 
to  prevent  them  from  being  diverted  to  the  illicit  manufacture  of  synthetic  drugs.  This 
could  be  done  by  drawing  up  suitable  monitoring  measures  that  would  reconcile  the 
legitimate interests of business with the imperatives of action to combat synthetic drugs. 

In view  of the very  changeable  nature  of  this  phenomenon  and the  wide  range  of basic 
chemical  substances that can be used, a targeted  response is required.  And as NSDs can 
be  very  simple  to  produce,  with  "recipes"  available  on  the  Internet  or  in  specialist 
publications,  there  is  also  the  question  of  whether  it  is  wise  to  make  public  the  list  of 
precursors to be monitored. 

The NSDs  affecting  the European  Union are mostly  produced  in certain Member  States 
and  in  a number  of  Central  and  Eastern  European  countries.  The  response  in terms  of 
controls on precursors therefore has to cover both the commercial  use of these  products 
inside the Community and trade with non-member countries. 

A uniform response across the entire Union is essential, since supplies to traffickers  would 
otherwise  quickly  be  diverted  to  Member  States  where  there  was  no  monitoring 
mechanism. 

The threat  of NSDs  is not  confined  solely  to  Europe.  Meetings  of  experts  are therefore 
under  way  at  international  level.  In  particular,  mention  should  be  made  of  the  two 
meetings already held under the auspices  of the  United Nations from 12 to  16 February 
1996  in  Vienna  and  from  25  to  29  November  1996  in  Shanghai.  In  addition  the 
Commission,  together  with  the  US  Drug  Enforcement  Administration,  organized  an 
international  conference  on precursors from  11 to  14 February  1997 in Prague,  at which 
the substances used to produce NSDs received considerable attention. 

The extraordinary UN General Assembly to be held in 1998 on the fight  against drugs will 
boost  the  effort  to  tackle  the  problem.  Several  preparatory  meetings  are  already 
scheduled,  starting in July, and it is vital for the Community to define a common position 
on the issue fairly quickly in order to be able to make a positive contribution to the debate 
so that real progress can be made in the fight against new synthetic drugs. 

2.-  Current legislation on precursors 

Community  legislation  on  precursors  involves  a  two-pronged  approach  to  cover  the 
internal and the external aspects. 

On the internal  side, the basic legislation  is Council  Directive 92/109/EEC,  amended by 
Commission Directive 93/46/EEC and supplemented by Commission Regulation 1485/96. 
The scope of the Directive covers the production  and marketing of the 22 internationally 
scheduled substances (1988 Vienna Convention). In outline, the mechanisms that apply on 
the internal front are: 

- 

- 

transactions  leading  to  the  marketing  of  classified  substances  (both  substances 
produced in the Community and those put into free circulation are covered) must be 
documented; this includes a declaration by the customer on their use; 

documents  must  be  kept  available  for  inspection  by  the  authorities  and  classified 
substances must be labelled; 

operators  producing  or  marketing  category  I  substances  must  be  licensed  and 
authorization is required to be supplied with, possess or handle them; 

- 

cooperation between the public authorities and operators is required. 

The  external  arrangements  are  based  on  Council  Regulation  (EEC)  No  3677/90,  as 
amended by Regulation (EEC) No 900/92. Implementing rules have been adopted by the 
Commission.  The  aim  is to  regulate  exports  of  the  22  scheduled  substances,  imposing 
obligations as regards: 

- 

- 

- 

- 

commercial documents, commercial records and the labelling of substances; 

the licensing and registering of operators; 

cooperation between public authorities and economic operators; and 

the issuing of export authorizations. 

These arrangements are backed up by specific  agreements concluded  by the Community 
with  certain  non-member  countries.  At  present  there  are  agreements  with  the  Andean 
countries, Mexico  and the United  States. Negotiations  are under way with  Canada, the 
Mercosur countries, Chile and the ASEAN countries. A special clause on combating the 
diversion  of  precursors  has  also  been  included  in  most  association  or  economic 
cooperation agreements concluded with non-member countries. 

3.  The weaknesses of current legislation with regard to the problem of NSDs 

The mechanisms established  by the instruments  cited  above are inadequate  to  deal with 
the problem of NSDs. The main shortcomings are: 

ii 

(a) Monitoring  mechanisms involved 

The current  system relates to  a limited  number  of products  (22), with  strict  controls  laid 
down  by  the  Directive  and  the  Regulation.  The  nature  of  the  controls  reflects  the 
diversion  methods  likely  to  affect  the  products  in  question,  depending  in  particular  on 
their  nature,  their  availability  on  the  market  and  the  type  of  drug  or  psychotropic 
substance they can be used to make. 

To  control  exports,  an  export  authorization  (individual  or  comprehensive)  is  required, 
depending  on  the  volume  of  substances  traded  or  the  country  of  destination.  In  some 
cases  authorization  is  granted  only  if  an  import  authorization  is  first  issued  in  the 
destination  country.  Although  simplifications  have  been  introduced  wherever  possible, 
using  criteria  such  as  the  integrity  and  competence  of  the  applicant,  the  system 
nevertheless imposes considerable constraints on the economic operators concerned. 

These  constraints  cannot  be  extended  too  far,  since  any  restrictive  system  will  only 
function  well  if  it  is  targeted  and  involves  no  more  than  a  reasonable  number  of 
substances  and  obligations.  It  must  also be borne  in mind  that  besides these  mechanisms, 
close  and  fruitful  cooperation  has  been  established  between  the  national  authorities  and 
operators  under  the  Community  legislation.  Broadening  the  constraints  rashly  would 
inevitably  undermine  such  cooperation  and  hence  the  effectiveness  of  the  entire 
arrangements to combat the diversion of precursors. 

(b) Type and number of substances subject to monitoring 

The  Community  legislation  currently  covers  22  substances,  only  8  of  which  relate  to 
synthetic  drugs  (including  methaqualone  and  LSD).  The  international  efforts  referred  to 
earlier  and  the  work  done  in  the  Community  committee  on  precursors  have  identified 
many other substances used to manufacture NSDs. 

At present there is no agreement  or scientifically  backed  view on which precursors  should 
be  subject  to  monitoring  at  Community  level.  The  main  options  range  between  6  and 
62 new  substances.  There  is,  however,  a general  consensus  (among  economic  operators 
and  monitoring  authorities)  that  it  would  be  inappropriate  and  impossible  in  practice  to 
apply  to  these  substances  the  mechanisms  provided  for  by  the  current  Community 
legislation. 

The Union's main partners, and notably the USA, all take the same view and are working 
to draw up a "special monitoring list" involving new monitoring methods. 

4.  The problems that have to be tackled 

These issues can be grouped under four headings: 

-  What  products  should  be  included  to  meet  current  requirements?  Is  there  a  lawful 
use for  all the products  concerned?  Which  ones  can be lawfully  used  so  widely  that 
monitoring them would be impossible or undesirable? 

H 

What  monitoring  mechanisms  (covering  substances 
themselves  and  suspect 
transactions or orders) should be set up so that  the system as a whole is manageable 
and  effective  and  allows  uniform  arrangements  across  the  entire  territory  of  the 
Union? 

What  mechanisms  should  be  established  for  adapting  the  rules  in  order  to  respond 
quickly  to  the  very  marked  changeability  of  the  precursors  used  to  manufacture 
NSDs,  in particular  in response  to  information  obtained  through  the  cooperation  of 
economic  operators? 

Would  it  be  wise  to  make  the  list  of  precursors  concerned  public,  especially  if, 
through  cooperation  with  operators,  the  goal  is  also  to  pinpoint  new  developments 
as early as possible and detect  suspect  orders? 

5.  The Commission's  approach 

Commission  departments  are  working  with  national  experts  in  an  attempt  to  define  a 
suitable  coherent  system  to  tackle  the  the  problems  of  NSDs.  There  are  no  obvious 
answers  to  the  questions  listed  above  and  some  technical  work  needs  to  be  pursued  in 
greater  depth.  Contacts  with the  economic  operators  concerned  also  need  to  be  pursued 
in this direction, both at national and Community level. 

It  is therefore  felt  that  the  Community  reaction  on  the  issue  of  the  precursors  used  for 
making NSDs should focus on the following  points: 

(a) 
Presentation  of a proposal  to  amend  the Regulation  on the external  aspects  (legal 
basis: Article  113 of the Treaty). The monitoring mechanisms for  the new substances that 
will be defined  should not include such measures as the issuing of licences and should  rest 
primarily  on  cooperation  with  the  economic  operators  concerned,  bearing  in  mind  the 
positive experience of some Member  States so far  and the legitimate concerns of industry. 
Explicit  provision  could  be  made  for  monitoring  other  substances  used  as  precursors, 
provided that the information  so gathered is regularly shared in the Community  committee 
on precursors in order to keep pace with developments on the ground. 

(b) 
Presentation  of  a  proposal  to  amend  the  Directive  on  the  internal  aspects  (legal 
basis:  Article  100a  of  the  Treaty).  Both  the  mechanism  applied  and  the  substances 
covered  would  have to be the  same as in the  proposed  amendment  to  the Regulation.  A 
separate  instrument  is  needed  to  cover  the  manufacture  and  placing  on  the  Community 
market of these substances, in addition to their export. 

Rapid  decision  on  the  Community  position  on  the  issue  with  an  eye  to  the 
(c) 
forthcoming  discussions  in  the  United  Nations.  The  only  way  for  the  Union  and  the 
Member  States to exert  real influence  on the course of the discussions is to  put  forward  a 
single,  united  position  vis  à  vis  our  partners.  This  is  essential  to  obtain  an  effective 
outcome  in  terms  of  combating  NSDs  but  also  to  prevent  international  agreement  on 
mechanisms that  do  not  suit  our  needs and  are  out  of line with  the approach  we want  to 
follow. 

là 

(d) 
In view of the large volume  of NSDs  being  made  in the  countries  of Central  and 
Eastern Europe (most of which are seeking membership of the Union), it is essential,  once 
the Community  has decided  how it wishes to  alter  its own  system, to launch  action  under 
the  Phare  programme  to  supplement  the  measures  already  taken  in  respect  of  these 
countries  in  terms  of  preparing  their  legislation  on  precursors.  In  addition,  specific 
agreements  should be concluded  with them, along the lines of those concluded  with  other 
non-member countries on precursors, in order to reinforce  the overall  effectiveness  of our 
respective  arrangements,  since  it  will  be  some  years  before  those  countries  actually 
become members. 

6.  Timetable for action 

To reconcile the need for a swift  reaction to the current  challenges and the need to  finalize 
effective  measures,  proposals  for  measures  on  points  (a)  and  (b)  ought  to  be  ready  by 
early autumn. The timing ties in with action on point  (c), where the Union will have to be 
ready  to  put  forward  the  Community  position  in the  appropriate  international  forums  by 
October. 

As  far  as  action  on  point  (d)  is  concerned,  this  cannot  reasonably  begin  (request  to  the 
Council  for  a  negotiating  brief)  until  the  Council  has  adopted  the  new  legislation.  This 
could be early in  1998 if the Regulation (based on Article  113) is adopted quickly. 

tu 

FINANCIAL STATEMENT 

1 

2 

3 

4 

4.1 

TITLE OF OPERATION 
Communication from the Commission to the Council and the European 
Parliament on the control of new synthetic drugs. 

BUDGET HEADING INVOLVED 
A-2511 Expenditure on meetings of Committees whose consultation is not 
compulsory in the procedure for drafting Community legislation. 

LEGAL BASIS 
In discussion in the Council. 

DESCRIPTION OF OPERATION 

General obj ective 
To  clarify  the  Commission's views concerning  the  surveillance  of  precursors 
on synthetic drugs, the creation of an early warning and risk assessment system 
for  synthetic  drugs  in view  of a  possible  interdiction  by the  Council.  In  this 
framework,  the Commission envisages the creation of a Technical Committee 
for assessing the risk posed  by new synthetic drugs. The Committee would be 
chaired by the Commission. 

4.2 

Period covered and arrangements for renewal 

undefinite 

5 

CLASSIFICATION OF EXPENDITURE OR REVENUE 

5.1 

Non-compulsory expenditure 

5.2 

Non-differentiated  appropriations 

TYPE OF EXPENDITURE OR REVENUE 
Not relevant 

1> 

7 

FINANCIAL IMPACT (Part B of the Budget) 

Not relevant 

8  FRAUD PREVENTION MEASURES 

Not relevant 

9 

ELEMENTS OF COST-EFFECTIVENESS ANALYSIS 

If the Committee chaired by the Commission and which is mentioned in the Presidency 
proposal for  a joint  action  on an early warning  system for  synthetic  drugs would  be 
created, its mission would be to assess the possible risks, including the health and social 
risks, caused by the traffic  in and use of synthetic drugs. 

10 

ADMINISTRATIVE EXPENDITURE  (SECTION m,  PART A  OF THE BUDGET) 

Actual  mobilisation  of  the  necessary  administrative  resources  will depend on the 
Commission annual decision  on  the allocation  of resources, taking 
into account the 
number of staff and additional amounts authorised  by the budgetary authority. 

10.1  Effect  on the number of posts 

Type of post 

Staff to beassigned to 
managing the operation 
Permanent 
posts 

Temporary 
posts 

Officials or 
temporary 
staff 

A 

B 

C 

Other resources 

TVx+al 

1 

0,5 

1,5 

Source 

Duration 

Additional 
resources 

• 

Existing 
resources in 
theDGor 
department 
concerned 
1 

0,5 

1,5 

1ST 

10.2 

Overall financial  impact of additional human resources 

Amounts 

Method of calculation 

ECU 

Officials 
Temporary staff 
O t h er  reSOUrCeS (indicate budget heading) 

Total  1 

1 

10.3  Increase in other administrative expenditure as a result of the operation 

Budget heading 
A-2511 

ECU 

Amounts 
20,000 

Method of calculation 

2 Committee meetings/year 
15 experts per Committee 
(695 Ecu/expert) 

Total  1  20,000 

| 

19 

ISSN 0254-1475 

COM(97) 249  final 

DOCUMENTS 

EN 

15  05  06 

Catalogue  number  :  CB-CO-97-235-EN-C 

ISBN 92-78-20109-X 

Office  for  Official  Publications of the European  Communities 

L-2985  Luxembourg